BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1920729 · Received December 7, 2010

    Report

    Report Number
    MW5018518
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON INITIAL PT AIRWAY ASSESSMENT RESISTANCE MET WHILE ATTEMPTING TO PASS BALLARD SX CATHETER, IN ADDITION, AUDIBLE LEAK HEARD, AIR INSERTED WITH SYRINGE, LEAK CONTINUED, PILOT BALLOON APPEARED FULL. DOCTOR CALLED TO BEDSIDE, PT EXTUBATED. PILOT BALLOON TESTED ONCE PT WAS EXTUBATED AND ONLY HALF BALLOON INFLATED. TUBE EXAMINED AFTER REMOVAL WIRING INSIDE ETT APPEARED TO BE OBSTRUCT ETT. NURSE ORALLY SXN PIECE OF CLEAR PLASTIC. PT VSS T/O. MANAGER TOOK ETT TO SURGERY DEPT TO TALK TO OPERATING ROOM MANAGER FOR FURTHER INVESTIGATION. DATES OF USE: (B)(6) 2010. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC EMG ENDOTRACHEAL TUBE BTR MEDTRONIC 65179200

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR